The invention relates to the field of aerosol formulations, packaging for dispersing such and devices for the delivery of aerosols. More specifically, the invention relates to formulations containing additives with distinct tastes, colors, smells and/or emmitors of gamma radiation and aerosol devices with sensors designed to monitor the formation and delivery of such aerosols.
Aerosolizing formulations for inhalation has been considered as a convenient alternative to injection for decades. This alternative to injections is particularly interesting for drugs which cannot be delivered orally, e.g. insulin. Although most compounds will effectively move from the lungs into the circulatory system there is considerable unpredictability in how much aerosolized formulation reaches the areas of the lungs where the material can move into the circulatory system. This results in inefficiency and unpredictability of dosing. A number of devices have been proposed for improving the efficiency of aerosol delivery, monitoring patients and teaching patients to correctly use delivery devices. The present invention makes it easy for the user to directly monitor aspects of aerosol delivery in a manner which improves repeatability of dosing.
Aerosolizable formulations are disclosed comprising a pharmaceutically acceptable carrier, a pharmaceutically active drug or detectably labeled compound and a sensory compound which is recognized by its distinct taste, color and/or smell even when present in a small amount and a low concentration. Examples of such sensory compounds include menthol, peppermint, cinnamon and vanilla flavors as well as dyes which have colors which contrast with the color of the inner mouth and throat. The compounds can be designed so that they are detectable by a specific area of the tongue, i.e., the specific area which preferentially detects sweet, salty, sour or bitter flavors. The degree of detection of the taste or smell of the compound and the perceived taste or smell is an indication of the degree of success in the delivery of an aerosolized formulation to a patient, with little or no taste detection indicating delivery predominately to the lung. When a color component is included such as a dark blue or purple dye the lack of any such coloring inside the mouth or throat after delivery is an indication of a successful delivery. The formulation is preferably delivered from a device which monitors and records information relating to the patient""s respiratory movement and also scans and analyzes the aerosol prior to inhalation. The device sends the user a visual and/or audible signal which informs the user about the character of the aerosol formed. By means of the color, taste and smell sensed as well as the signal obtained from the device the user is provided with multiple indications of the efficacy of the aerosolized dose delivered. These indications assist the user in improving delivery techniques, and in analyzing the effectiveness of a given delivery procedure after it has been performed thereby improving repeatability of dosing. The sensory compounds may be used together, separately or in any combination and may be used with or without a device which monitors one or more respiratory parameters.
An object of the invention is to provide an aerosol formulation which comprises a sensory compound having a color, taste and/or smell which provides the user with an indication of the efficacy of aerosol delivery.
Another object is to provide formulations which comprise compounds which emit radiation which is detectable by counters or cameras which detect the particular radiation emitted e.g. gamma emissions.
Another object is to provide a device for aerosolizing formulations which monitors the physical characteristics of aerosols created (e.g. particle size) and provides the user with an audio and/or visual signal which indicates the character of the aerosol.
Another object is to provide a formulation with a taste which is particularly noted on contact with a particular area of the tongue thereby allowing a user to determine how a particular aerosolized burst was misdirected.
Another object is to provide a system of delivery of aerosols which causes the patient to become accustomed to certain sensory perceptions during a normal delivery event, such that an abnormal delivery will be perceived by the patient as different.
An advantage of the invention is that it provides a device with a formulation which uses the electronic sensory components available in the device along with the users own senses to monitor the delivery of aerosolized doses.
A feature of a formulation of the invention is that it has a distinct detectable color, taste and/or smell.
Another feature of the invention is that an optical scanner is used to characterize aerosols formed.
An advantage of the invention is that the user is quickly and conveniently provided with information indicative of the efficacy of delivery of an aerosolized dose.
These and other objects, advantages and features of the present invention will become apparent to those skilled in the art upon reading this disclosure in combination with drawings wherein like numerals refer to like components throughout.